SATURN 9000-810— 510(k) K080589

Substantially Equivalent

New Medical Co., Ltd.

FDA 510(k) clearance K080589 for SATURN 9000-810, Substantially Equivalent on 2008-06-11. Applicant: New Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: New Medical Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2008-03-03
Decision date: 2008-06-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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